A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Inclusion criteria:

• Participant must be ≥12 years of age at the time of signing informed consent

• Participant must have a study caregiver ≥18 years of age at the time of signing theinformed consent; the study caregiver(s) must be able to recognize and observe theparticipant's seizures

• Participants with an established diagnosis of focal or generalized epilepsy orcombined focal and generalized epilepsy with a documented history of stereotypicalepisodes of prolonged seizures that includes at least 1 of the following:

1. Generalized seizure episodes starting with a flurry of absence seizures ormyoclonic seizures with a minimum total duration of 5 minutes

2. Episodes of a focal seizure with a minimum duration of 3 minutes

3. Episodes of a focal seizure or a flurry of myoclonic seizures for at least 90seconds followed by a generalized/bilateral tonic-clonic seizure with a minimumtotal duration of 3 minutes

• Prior to the Screening Visit, participant completed a study using Staccatoalprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))

Exclusion Criteria:

• Participant has a current history of alcohol or drug use disorder, as defined in theDiagnostic and Statistical Manual of Mental Disorders 5, within the previous 1 year

• Participant has a known hypersensitivity to any components of the investigationalmedicinal product (IMP) or comparable drugs (and/or an investigational device) asstated in this protocol or to albuterol (or similar bronchospasm rescue medicationif needed to meet country-specific requirements)

• Participant has a history of convulsive (generalized tonic-clonic) statusepilepticus in the 8 weeks prior to the Screening Visit

• Participant has a history or presence of known nonepileptic seizures which cannot bedistinguished from qualifying epileptic seizures

• Participant has a clinically significant known airway hypersensitivity (eg,bronchospasm to known allergens, such as pollen, animals, or food) and/or acuterespiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation).NOTE: Participants with mild asthma who qualify for inclusion in the are allowed tobe enrolled even though they have known airway hypersensitivity

• Participant has a clinically significant chronic pulmonary disorder other than mildasthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic pulmonary fibrosis]) and/or recent history or presence ofhemoptysis or pneumothorax

• Participant has had a positive antigen test for severe acute respiratory syndromecoronavirus 2 (SARS-CoV-2) and experienced moderate to severe signs/symptoms ofrespiratory distress necessitating hospitalization or outpatient treatment such asambulatory oxygen, extensive treatment with inhaler medications, and/or oralmedications for a duration of 4 weeks or more, unless full resolution occurred atleast 6 months prior to Screening

• Participant has experienced a severe upper respiratory tract infection within 4weeks or severe bronchitis/pneumonia within 3 months before the Screening Visit

• Participant has a history or presence of acute narrow-angle glaucoma

• Participant has a condition for which oral alprazolam is contraindicated as per theregional labeling

• Participant is taking any drug that is a strong CYP3A4 inhibitor, including azoleantifungal agents (ketoconazole and itraconazole) and nefazodone

• Participant is taking any opioids or sedative hypnotics on a chronic basis

• Participant is taking nonselective beta blockers on a chronic basis